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121 STAT. 823PUBLIC LAW 11085SEPT. 27, 2007

Public Law 11085110th Congress

An Act

To amend the Federal Food, Drug, and Cosmetic Act to revise and extend theuser-fee programs for prescription drugs and for medical devices, to enhancethe postmarket authorities of the Food and Drug Administration with respectto the safety of drugs, and for other purposes.

Be it enacted by the Senate and House of Representatives of

the United States of America in Congress assembled,SECTION 1. SHORT TITLE.

This Act may be cited as the Food and Drug AdministrationAmendments Act of 2007.

SEC. 2. TABLE OF CONTENTS.

The table of contents for this Act is as follows:

Sec. 1. Short title.Sec. 2. Table of contents.

TITLE IPRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007

Sec. 101. Short title; references in title; finding.Sec. 102. Definitions.Sec. 103. Authority to assess and use drug fees.Sec. 104. Fees relating to advisory review of prescription-drug television adver-

tising.

Sec. 105. Reauthorization; reporting requirements.Sec. 106. Sunset dates.Sec. 107. Effective date.Sec. 108. Savings clause.Sec. 109. Technical amendment; conforming amendment.

TITLE IIMEDICAL DEVICE USER FEE AMENDMENTS OF 2007

Sec. 201. Short title; references in title; finding.

Subtitle AFees Related to Medical Devices

Sec. 211. Definitions.Sec. 212. Authority to assess and use device fees.Sec. 213. Reauthorization; reporting requirements.Sec. 214. Savings clause.Sec. 215. Additional authorization of appropriations for postmarket safety informa-

tion.Sec. 216. Effective date.Sec. 217. Sunset clause.

Subtitle BAmendments Regarding Regulation of Medical Devices

Sec. 221. Extension of authority for third party review of premarket notification.Sec. 222. Registration.Sec. 223. Filing of lists of drugs and devices manufactured, prepared, propagated,

and compounded by registrants; statements; accompanying disclosures.Sec. 224. Electronic registration and listing.Sec. 225. Report by Government Accountability Office.Sec. 226. Unique device identification system.Sec. 227. Frequency of reporting for certain devices.

21 USC 301 note.

Food and DrugAdministrationAmendments Actof 2007.

Sept. 27, 2007

[H.R. 3580]

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121 STAT. 824 PUBLIC LAW 11085SEPT. 27, 2007

Sec. 228. Inspections by accredited persons.Sec. 229. Study of nosocomial infections relating to medical devices.Sec. 230. Report by the Food and Drug Administration regarding labeling informa-

tion on the relationship between the use of indoor tanning devices and

development of skin cancer or other skin damage.TITLE IIIPEDIATRIC MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT

OF 2007

Sec. 301. Short title.Sec. 302. Tracking pediatric device approvals.Sec. 303. Modification to humanitarian device exemption.Sec. 304. Encouraging pediatric medical device research.Sec. 305. Demonstration grants for improving pediatric device availability.Sec. 306. Amendments to office of pediatric therapeutics and pediatric advisory

committee.Sec. 307. Postmarket surveillance.

TITLE IVPEDIATRIC RESEARCH EQUITY ACT OF 2007

Sec. 401. Short title.Sec. 402. Reauthorization of Pediatric Research Equity Act.Sec. 403. Establishment of internal committee.Sec. 404. Government Accountability Office report.

TITLE VBEST PHARMACEUTICALS FOR CHILDREN ACT OF 2007Sec. 501. Short title.Sec. 502. Reauthorization of Best Pharmaceuticals for Children Act.Sec. 503. Training of pediatric pharmacologists.

TITLE VIREAGAN-UDALL FOUNDATION

Sec. 601. The Reagan-Udall Foundation for the Food and Drug Administration.Sec. 602. Office of the Chief Scientist.Sec. 603. Critical path public-private partnerships.

TITLE VIICONFLICTS OF INTEREST

Sec. 701. Conflicts of interest.

TITLE VIIICLINICAL TRIAL DATABASES

Sec. 801. Expanded clinical trial registry data bank.

TITLE IXENHANCED AUTHORITIES REGARDING POSTMARKET SAFETYOF DRUGS

Subtitle APostmarket Studies and Surveillance

Sec. 901. Postmarket studies and clinical trials regarding human drugs; risk eval-uation and mitigation strategies.

Sec. 902. Enforcement.Sec. 903. No effect on withdrawal or suspension of approval.Sec. 904. Benefit-risk assessments.Sec. 905. Active postmarket risk identification and analysis.Sec. 906. Statement for inclusion in direct-to-consumer advertisements of drugs.Sec. 907. No effect on veterinary medicine.Sec. 908. Authorization of appropriations.Sec. 909. Effective date and applicability.

Subtitle BOther Provisions to Ensure Drug Safety and Surveillance

Sec. 911. Clinical trial guidance for antibiotic drugs.Sec. 912. Prohibition against food to which drugs or biological products have been

added.Sec. 913. Assuring pharmaceutical safety.Sec. 914. Citizen petitions and petitions for stay of agency action.

Sec. 915. Postmarket drug safety information for patients and providers.Sec. 916. Action package for approval.Sec. 917. Risk communication.Sec. 918. Referral to advisory committee.Sec. 919. Response to the institute of medicine.Sec. 920. Database for authorized generic drugs.Sec. 921. Adverse drug reaction reports and postmarket safety.

TITLE XFOOD SAFETY

Sec. 1001. Findings.


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Sec. 1002. Ensuring the safety of pet food.Sec. 1003. Ensuring efficient and effective communications during a recall.Sec. 1004. State and Federal Cooperation.Sec. 1005. Reportable Food Registry.

Sec. 1006. Enhanced aquaculture and seafood inspection.Sec. 1007. Consultation regarding genetically engineered seafood products.Sec. 1008. Sense of Congress.Sec. 1009. Annual report to Congress.Sec. 1010. Publication of annual reports.Sec. 1011. Rule of construction.

TITLE XIOTHER PROVISIONS

Subtitle AIn General

Sec. 1101. Policy on the review and clearance of scientific articles published byFDA employees.

Sec. 1102. Priority review to encourage treatments for tropical diseases.Sec. 1103. Improving genetic test safety and quality.Sec. 1104. NIH Technical amendments.Sec. 1105. Severability clause.

Subtitle BAntibiotic Access and Innovation

Sec. 1111. Identification of clinically susceptible concentrations of antimicrobials.Sec. 1112. Orphan antibiotic drugs.Sec. 1113. Exclusivity of certain drugs containing single enantiomers.Sec. 1114. Report.

TITLE IPRESCRIPTION DRUG USERFEE AMENDMENTS OF 2007

SEC. 101. SHORT TITLE; REFERENCES IN TITLE; FINDING.

(a) SHORT TITLE.This title may be cited as the PrescriptionDrug User Fee Amendments of 2007.

(b) REFERENCES IN TITLE.Except as otherwise specified,amendments made by this title to a section or other provisionof law are amendments to such section or other provision of the

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).(c) FINDING.The Congress finds that the fees authorized bythe amendments made in this title will be dedicated toward expe-diting the drug development process and the process for the reviewof human drug applications, including postmarket drug safetyactivities, as set forth in the goals identified for purposes of part2 of subchapter C of chapter VII of the Federal Food, Drug, andCosmetic Act, in the letters from the Secretary of Health andHuman Services to the Chairman of the Committee on Health,Education, Labor, and Pensions of the Senate and the Chairmanof the Committee on Energy and Commerce of the House of Rep-resentatives, as set forth in the Congressional Record.

SEC. 102. DEFINITIONS.

Section 735 (21 U.S.C. 379g) is amended(1) in the matter before paragraph (1), by striking For

purposes of this subchapter and inserting For purposes ofthis part;

(2) in paragraph (1)(A) in subparagraph (A), by striking 505(b)(1), and

inserting 505(b), or;(B) by striking subparagraph (B);(C) by redesignating subparagraph (C) as subpara-

graph (B); and

21 USC 379gnote.

21 USC 301 note.

PrescriptionDrug User FeeAmendments of2007.


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(D) in the matter following subparagraph (B), as soredesignated, by striking subparagraph (C) and insertingsubparagraph (B);

(3) in paragraph (3)(C)(A) by striking 505(j)(7)(A) and inserting 505(j)(7)(A)(not including the discontinued section of such list); and

(B) by inserting before the period (not including thediscontinued section of such list);(4) in paragraph (4), by inserting before the period at

the end the following: (such as capsules, tablets, or lyophilizedproducts before reconstitution);

(5) by amending paragraph (6)(F) to read as follows:(F) Postmarket safety activities with respect to drugs

approved under human drug applications or supplements,including the following activities:

(i) Collecting, developing, and reviewing safetyinformation on approved drugs, including adverseevent reports.

(ii) Developing and using improved adverse-eventdata-collection systems, including information tech-nology systems.

(iii) Developing and using improved analyticaltools to assess potential safety problems, includingaccess to external data bases.

(iv) Implementing and enforcing section 505(o)(relating to postapproval studies and clinical trials andlabeling changes) and section 505(p) (relating to riskevaluation and mitigation strategies).

(v) Carrying out section 505(k)(5) (relating toadverse event reports and postmarket safety activi-ties).;

(6) in paragraph (8)(A) by striking April of the preceding fiscal year

and inserting October of the preceding fiscal year; and(B) by striking April 1997 and inserting October

1996;(7) by redesignating paragraph (9) as paragraph (11); and(8) by inserting after paragraph (8) the following para-

graphs:(9) The term person includes an affiliate thereof.(10) The term active, with respect to a commercial inves-

tigational new drug application, means such an applicationto which information was submitted during the relevantperiod..

SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES.

(a) TYPES OF FEES.Section 736(a) (21 U.S.C. 379h(a)) isamended

(1) in the matter preceding paragraph (1), by striking

2003 and inserting 2008;(2) in paragraph (1)

(A) in subparagraph (D)(i) in the heading, by inserting OR WITHDRAWN

BEFORE FILING after REFUSED FOR FILING; and(ii) by inserting before the period at the end the

following: or withdrawn without a waiver beforefiling;


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(B) by redesignating subparagraphs (E) and (F) assubparagraphs (F) and (G), respectively; and

(C) by inserting after subparagraph (D) the following:

(E) FEES FOR APPLICATIONS PREVIOUSLY REFUSED FORFILING OR WITHDRAWN BEFORE FILING.A human drugapplication or supplement that was submitted but wasrefused for filing, or was withdrawn before being acceptedor refused for filing, shall be subject to the full fee undersubparagraph (A) upon being resubmitted or filed overprotest, unless the fee is waived or reduced under sub-section (d).; and(3) in paragraph (2)

(A) in subparagraph (A), by striking subparagraph(B) and inserting subparagraphs (B) and (C); and

(B) by adding at the end the following:(C) SPECIAL RULES FOR POSITRON EMISSION TOMOG-

RAPHY DRUGS.(i) IN GENERAL.Except as provided in clause

(ii), each person who is named as the applicant inan approved human drug application for a positronemission tomography drug shall be subject undersubparagraph (A) to one-sixth of an annual establish-ment fee with respect to each such establishmentidentified in the application as producing positronemission tomography drugs under the approvedapplication.

(ii) EXCEPTION FROM ANNUAL ESTABLISHMENTFEE.Each person who is named as the applicant inan application described in clause (i) shall not beassessed an annual establishment fee for a fiscal yearif the person certifies to the Secretary, at a time speci-fied by the Secretary and using procedures specified

by the Secretary, that(I) the person is a not-for-profit medical centerthat has only 1 establishment for the productionof positron emission tomography drugs; and

(II) at least 95 percent of the total numberof doses of each positron emission tomography drugproduced by such establishment during such fiscalyear will be used within the medical center.(iii) DEFINITION.For purposes of this subpara-

graph, the term positron emission tomography drughas the meaning given to the term compoundedpositron emission tomography drug in section 201(ii),except that paragraph (1)(B) of such section shall notapply..

(b) FEE REVENUEAMOUNTS.Section 736(b) (21 U.S.C. 379h(b))

is amended to read as follows:(b) FEE REVENUEAMOUNTS.(1) IN GENERAL.For each of the fiscal years 2008 through

2012, fees under subsection (a) shall, except as provided insubsections (c), (d), (f), and (g), be established to generatea total revenue amount under such subsection that is equalto the sum of

(A) $392,783,000; and


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(B) an amount equal to the modified workload adjust-ment factor for fiscal year 2007 (as determined under para-graph (3)).

(2) TYPES OF FEES.Of the total revenue amount deter-mined for a fiscal year under paragraph (1)(A) one-third shall be derived from fees under sub-

section (a)(1) (relating to human drug applications andsupplements);

(B) one-third shall be derived from fees under sub-section (a)(2) (relating to prescription drug establishments);and

(C) one-third shall be derived from fees under sub-section (a)(3) (relating to prescription drug products).(3) MODIFIED WORKLOAD ADJUSTMENT FACTOR FOR FISCAL

YEAR 2007.For purposes of paragraph (1)(B), the Secretaryshall determine the modified workload adjustment factor bydetermining the dollar amount that results from applying themethodology that was in effect under subsection (c)(2) for fiscal

year 2007 to the amount $354,893,000, except that, with respectto the portion of such determination that is based on thechange in the total number of commercial investigational newdrug applications, the Secretary shall count the number ofsuch applications that were active during the most recent 12-month period for which data on such submissions is available.

(4) ADDITIONAL FEE REVENUES FOR DRUG SAFETY.(A) IN GENERAL.For each of the fiscal years 2008

through 2012, paragraph (1)(A) shall be applied by sub-stituting the amount determined under subparagraph (B)for $392,783,000.

(B) AMOUNT DETERMINED.For each of the fiscal years2008 through 2012, the amount determined under thissubparagraph is the sum of

(i) $392,783,000; plus(ii)(I) for fiscal year 2008, $25,000,000;(II) for fiscal year 2009, $35,000,000;(III) for fiscal year 2010, $45,000,000;(IV) for fiscal year 2011, $55,000,000; and(V) for fiscal year 2012, $65,000,000..

(c) ADJUSTMENTS TO FEES.(1) INFLATION ADJUSTMENT.Section 736(c)(1) (21 U.S.C.

379h(c)(1)) is amended(A) in the matter preceding subparagraph (A), by

striking The revenues established in subsection (b) andinserting For fiscal year 2009 and subsequent fiscal years,the revenues established in subsection (b);

(B) in subparagraph (A), by striking or at the end;(C) in subparagraph (B), by striking the period at

the end and inserting , or;(D) by inserting after subparagraph (B) the following:

(C) the average annual change in the cost, per full-time equivalent position of the Food and Drug Administra-tion, of all personnel compensation and benefits paid withrespect to such positions for the first 5 years of the pre-ceding 6 fiscal years.; and

(E) in the matter following subparagraph (C) (as addedby subparagraph (D)), by striking fiscal year 2003 andinserting fiscal year 2008.

Applicability.


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(2) WORKLOAD ADJUSTMENT.Section 736(c)(2) (21 U.S.C.379h(c)(2)) is amended

(A) in the matter preceding subparagraph (A), by

striking Beginning with fiscal year 2004, and insertingFor fiscal year 2009 and subsequent fiscal years,;(B) in subparagraph (A), in the first sentence

(i) by striking human drug applications, andinserting human drug applications (adjusted forchanges in review activities, as described in the noticethat the Secretary is required to publish in the FederalRegister under this subparagraph),;

(ii) by striking commercial investigational newdrug applications,; and

(iii) by inserting before the period the following:, and the change in the total number of active commer-cial investigational new drug applications (adjustedfor changes in review activities, as so described) duringthe most recent 12-month period for which data on

such submissions is available;(C) in subparagraph (B), by adding at the end thefollowing: Any adjustment for changes in review activitiesmade in setting fees and revenue amounts for fiscal year2009 may not result in the total workload adjustmentbeing more than 2 percentage points higher than it wouldhave been in the absence of the adjustment for changesin review activities.; and

(D) by adding at the end the following:(C) The Secretary shall contract with an independent

accounting firm to study the adjustment for changes inreview activities applied in setting fees and revenueamounts for fiscal year 2009 and to make recommendations,if warranted, for future changes in the methodology forcalculating the adjustment. After review of the rec-ommendations, the Secretary shall, if warranted, makeappropriate changes to the methodology, and the changesshall be effective for each of the fiscal years 2010 through2012. The Secretary shall not make any adjustment forchanges in review activities for any fiscal year after 2009unless such study has been completed..(3) RENT AND RENT-RELATED COST ADJUSTMENT.Section

736(c) (21 U.S.C. 379h(c)) is amended(A) by redesignating paragraphs (3), (4), and (5) as

paragraphs (4), (5), and (6), respectively; and(B) by inserting after paragraph (2) the following:

(3) RENT AND RENT-RELATED COST ADJUSTMENT.For fiscalyear 2010 and each subsequent fiscal year, the Secretary shall,before making adjustments under paragraphs (1) and (2),decrease the fee revenue amount established in subsection (b)if actual costs paid for rent and rent-related expenses for the

preceding fiscal year are less than estimates made for suchyear in fiscal year 2006. Any reduction made under this para-graph shall not exceed the amount by which such costs fallbelow the estimates made in fiscal year 2006 for such fiscalyear, and shall not exceed $11,721,000 for any fiscal year..

(4) FINAL YEAR ADJUSTMENT.Paragraph (4) of section736(c) (21 U.S.C. 379h(c)), as redesignated by paragraph (3)(A),is amended to read as follows:

Effective date.

Contracts.Study.


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(4) FINAL YEAR ADJUSTMENT.(A) INCREASE IN FEES.For fiscal year 2012, the Sec-

retary may, in addition to adjustments under this para-

graph and paragraphs (1), (2), and (3), further increasethe fee revenues and fees established in subsection (b)if such an adjustment is necessary to provide for not morethan 3 months of operating reserves of carryover userfees for the process for the review of human drug applica-tions for the first 3 months of fiscal year 2013. If suchan adjustment is necessary, the rationale for the amountof the increase shall be contained in the annual noticeestablishing fee revenues and fees for fiscal year 2012.If the Secretary has carryover balances for such processin excess of 3 months of such operating reserves, the adjust-ment under this subparagraph shall not be made.

(B) DECREASE IN FEES.(i) IN GENERAL.For fiscal year 2012, the Sec-

retary may, in addition to adjustments under this para-

graph and paragraphs (1), (2), and (3), decrease thefee revenues and fees established in subsection (b)by the amount determined in clause (ii), if, for fiscalyear 2009 or 2010

(I) the amount of the total appropriations forthe Food and Drug Administration for such fiscalyear (excluding the amount of fees appropriatedfor such fiscal year) exceeds the amount of thetotal appropriations for the Food and Drug

Administration for fiscal year 2008 (excluding theamount of fees appropriated for such fiscal year),adjusted as provided under paragraph (1); and

(II) the amount of the total appropriationsexpended for the process for the review of humandrug applications at the Food and Drug Adminis-

tration for such fiscal year (excluding the amountof fees appropriated for such fiscal year) exceedsthe amount of appropriations expended for theprocess for the review of human drug applicationsat the Food and Drug Administration for fiscalyear 2008 (excluding the amount of fees appro-priated for such fiscal year), adjusted as providedunder paragraph (1).(ii) AMOUNT OF DECREASE.The amount deter-

mined in this clause is the lesser of(I) the amount equal to the sum of the

amounts that, for each of fiscal years 2009 and2010, is the lesser of

(aa) the excess amount described inclause (i)(II) for such fiscal year; or

(bb) the amount specified in subsection(b)(4)(B)(ii) for such fiscal year; or(II) $65,000,000.

(iii) LIMITATIONS.(I) FISCAL YEAR CONDITION.In making the

determination under clause (ii), an amountdescribed in subclause (I) of such clause for fiscalyear 2009 or 2010 shall be taken into account


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only if subclauses (I) and (II) of clause (i) applyto such fiscal year.

(II) RELATION TO SUBPARAGRAPH (A).The

Secretary shall limit any decrease under this para-graph if such a limitation is necessary to providefor the 3 months of operating reserves describedin subparagraph (A)..

(5) LIMIT.Paragraph (5) of section 736(c) (21 U.S.C.379h(c)), as redesignated by paragraph (3)(A), is amended bystriking 2002 and inserting 2007.(d) FEE WAIVER OR REDUCTION.Section 736(d) (21 U.S.C.

379h(d)) is amended(1) in paragraph (1), in the matter preceding subparagraph

(A)(A) by inserting after The Secretary shall grant the

following: to a person who is named as the applicantin a human drug application; and

(B) by inserting to that person after one or more

fees assessed;(2) by redesignating paragraphs (2) and (3) as paragraphs

(3) and (4), respectively;(3) by inserting after paragraph (1) the following:(2) CONSIDERATIONS.In determining whether to grant

a waiver or reduction of a fee under paragraph (1), the Secretaryshall consider only the circumstances and assets of theapplicant involved and any affiliate of the applicant.; and

(4) in paragraph (4) (as redesignated by paragraph (2)),in subparagraph (A), by inserting before the period the fol-lowing: , and that does not have a drug product that hasbeen approved under a human drug application and introducedor delivered for introduction into interstate commerce.(e) CREDITING ANDAVAILABILITY OF FEES.

(1) AUTHORIZATION OF APPROPRIATIONS.Section 736(g)(3)

(21 U.S.C. 379h(g)(3)) is amended to read as follows:(3) AUTHORIZATION OF APPROPRIATIONS.For each of the

fiscal years 2008 through 2012, there is authorized to be appro-priated for fees under this section an amount equal to thetotal revenue amount determined under subsection (b) for thefiscal year, as adjusted or otherwise affected under subsection(c) and paragraph (4) of this subsection..

(2) OFFSET.Section 736(g)(4) (21 U.S.C. 379h(g)(4)) isamended to read as follows:

(4) OFFSET.If the sum of the cumulative amount of feescollected under this section for the fiscal years 2008 through2010 and the amount of fees estimated to be collected underthis section for fiscal year 2011 exceeds the cumulative amountappropriated under paragraph (3) for the fiscal years 2008through 2011, the excess shall be credited to the appropriation

account of the Food and Drug Administration as provided inparagraph (1), and shall be subtracted from the amount offees that would otherwise be authorized to be collected underthis section pursuant to appropriation Acts for fiscal year2012..(f) EXEMPTION FOR ORPHAN DRUGS.Section 736 (21 U.S.C.

379h) is further amended by adding at the end the following:(k) ORPHAN DRUGS.


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(1) EXEMPTION.A drug designated under section 526 fora rare disease or condition and approved under section 505or under section 351 of the Public Health Service Act shall

be exempt from product and establishment fees under thissection, if the drug meets all of the following conditions:(A) The drug meets the public health requirements

contained in this Act as such requirements are appliedto requests for waivers for product and establishment fees.

(B) The drug is owned or licensed and is marketedby a company that had less than $50,000,000 in grossworldwide revenue during the previous year.(2) EVIDENCE OF QUALIFICATION.An exemption under

paragraph (1) applies with respect to a drug only if theapplicant involved submits a certification that its gross annualrevenues did not exceed $50,000,000 for the preceding 12months before the exemption was requested..(g) CONFORMING AMENDMENT.Section 736(a) (21 U.S.C.

379h(a)) is amended in paragraphs (1)(A)(i), (1)(A)(ii), (2)(A), and(3)(A) by striking (c)(4) each place such term appears and inserting(c)(5).

(h) TECHNICALAMENDMENT.(1) AMENDMENT.Section 736(g)(1) (21 U.S.C. 379h(g)(1))

is amended by striking the first sentence and inserting thefollowing: Fees authorized under subsection (a) shall be col-lected and available for obligation only to the extent and inthe amount provided in advance in appropriations Acts. Suchfees are authorized to remain available until expended..

(2) EFFECTIVE DATE.Paragraph (1) shall take effect asif included in section 504 of the Prescription Drug User Fee

Amendments of 2002 (Public Law 107188; 116 Stat. 687).

SEC. 104. FEES RELATING TO ADVISORY REVIEW OF PRESCRIPTION-

DRUG TELEVISION ADVERTISING.

Part 2 of subchapter C of chapter VII (21 U.S.C. 379g et

seq.) is amended by adding after section 736 the following:SEC. 736A. FEES RELATING TO ADVISORY REVIEW OF PRESCRIPTION-

DRUG TELEVISION ADVERTISING.

(a) TYPES OF DIRECT-TO-CONSUMER TELEVISION ADVERTISE-MENT REVIEW FEES.Beginning in fiscal year 2008, the Secretaryshall assess and collect fees in accordance with this section asfollows:

(1) ADVISORY REVIEW FEE.(A) IN GENERAL.With respect to a proposed direct-

to-consumer television advertisement (referred to in thissection as a DTC advertisement), each person that onor after October 1, 2007, submits such an advertisementfor advisory review by the Secretary prior to its initialpublic dissemination shall, except as provided in subpara-graph (B), be subject to a fee established under subsection

(c)(3).(B) EXCEPTION FOR REQUIRED SUBMISSIONS.A DTC

advertisement that is required to be submitted to the Sec-retary prior to initial public dissemination is not subjectto a fee under subparagraph (A) unless the sponsor des-ignates the submission as a submission for advisory review.

(C) NOTICE TO SECRETARY OF NUMBER OFADVERTISEMENTS.Not later than June 1 of each fiscalDeadlines.

Federal Register,publication.

Effective date.

21 USC 379h1.

21 USC 379hnote.


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year, the Secretary shall publish a notice in the FederalRegister requesting any person to notify the Secretarywithin 30 days of the number of DTC advertisements the

person intends to submit for advisory review in the nextfiscal year. Notwithstanding the preceding sentence, forfiscal year 2008, the Secretary shall publish such a noticein the Federal Register not later than 30 days after thedate of the enactment of the Food and Drug Administration

Amendments Act of 2007.(D) PAYMENT.

(i) IN GENERAL.The fee required by subpara-graph (A) (referred to in this section as an advisoryreview fee) shall be due not later than October 1of the fiscal year in which the DTC advertisementinvolved is intended to be submitted for advisoryreview, subject to subparagraph (F)(i). Notwithstandingthe preceding sentence, the advisory review fee forany DTC advertisement that is intended to be sub-

mitted for advisory review during fiscal year 2008 shallbe due not later than 120 days after the date of theenactment of the Food and Drug Administration

Amendments of 2007 or an earlier date as specifiedby the Secretary.

(ii) EFFECT OF SUBMISSION.Notification of theSecretary under subparagraph (C) of the number ofDTC advertisements a person intends to submit foradvisory review is a legally binding commitment bythat person to pay the annual advisory review feefor that number of submissions on or before October1 of the fiscal year in which the advertisement isintended to be submitted. Notwithstanding the pre-ceding sentence, the commitment shall be a legallybinding commitment by that person to pay the annualadvisory review fee for that number of submissionsfor fiscal year 2008 by the date specified in clause(i).

(iii) NOTICE REGARDING CARRYOVER SUBMIS-SIONS.In making a notification under subparagraph(C), the person involved shall in addition notify theSecretary if under subparagraph (F)(i) the personintends to submit a DTC advertisement for which theadvisory review fee has already been paid. If the persondoes not so notify the Secretary, each DTC advertise-ment submitted by the person for advisory review inthe fiscal year involved shall be subject to the advisoryreview fee.(E) MODIFICATION OF ADVISORY REVIEW FEE.

(i) LATE PAYMENT.If a person has submitteda notification under subparagraph (C) with respect

to a fiscal year and has not paid all advisory reviewfees due under subparagraph (D) not later thanNovember 1 of such fiscal year (or, in the case ofsuch a notification submitted with respect to fiscalyear 2008, not later than 150 days after the dateof the enactment of the Food and Drug Administration

Amendments Act of 2007 or an earlier date specifiedby the Secretary), the fees shall be regarded as late

Applicability.

Deadlines.


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and an increase in the amount of fees applies in accord-ance with this clause, notwithstanding any other provi-sion of this section. For such person, all advisory review

fees for such fiscal year shall be due and payable20 days before any direct-to-consumer advertisementis submitted to the Secretary for advisory review, andeach such fee shall be equal to 150 percent of thefee that otherwise would have applied pursuant tosubsection (c)(3).

(ii) EXCEEDING IDENTIFIED NUMBER OF SUBMIS-SIONS.If a person submits a number of DTCadvertisements for advisory review in a fiscal yearthat exceeds the number identified by the person undersubparagraph (C), an increase in the amount of feesapplies under this clause for each submission in excessof such number, notwithstanding any other provisionof this section. For each such DTC advertisement, theadvisory review fee shall be due and payable 20 daysbefore the advertisement is submitted to the Secretary,and the fee shall be equal to 150 percent of the feethat otherwise would have applied pursuant to sub-section (c)(3).(F) LIMITS.

(i) SUBMISSIONS.For each advisory review feepaid by a person for a fiscal year, the person is entitledto acceptance for advisory review by the Secretaryof one DTC advertisement and acceptance of oneresubmission for advisory review of the same advertise-ment. The advertisement shall be submitted for reviewin the fiscal year for which the fee was assessed, exceptthat a person may carry over not more than one paidadvisory review submission to the next fiscal year.

Resubmissions may be submitted without regard tothe fiscal year of the initial advisory review submission.(ii) NO REFUNDS.Except as provided by sub-

sections (d)(4) and (f), fees paid under this sectionshall not be refunded.

(iii) NO WAIVERS, EXEMPTIONS, OR REDUCTIONS.The Secretary shall not grant a waiver, exemption,or reduction of any fees due or payable under thissection.

(iv) RIGHT TO ADVISORY REVIEW NOT TRANSFER-ABLE.The right to an advisory review under thisparagraph is not transferable, except to a successorin interest.

(2) OPERATING RESERVE FEE.(A) IN GENERAL.Each person that on or after October

1, 2007, is assessed an advisory review fee under paragraph(1) shall be subject to fee established under subsection(d)(2) (referred to in this section as an operating reservefee) for the first fiscal year in which an advisory reviewfee is assessed to such person. The person is not subjectto an operating reserve fee for any other fiscal year.

(B) PAYMENT.Except as provided in subparagraph(C), the operating reserve fee shall be due no later than

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(i) October 1 of the first fiscal year in whichthe person is required to pay an advisory review feeunder paragraph (1); or

(ii) for fiscal year 2008, 120 days after the dateof the enactment of the Food and Drug AdministrationAmendments Act of 2007 or an earlier date specifiedby the Secretary.(C) LATE NOTICE OF SUBMISSION.If, in the first fiscal

year of a persons participation in the program under thissection, that person submits any DTC advertisements foradvisory review that are in excess of the number identifiedby that person in response to the Federal Register noticedescribed in subsection (a)(1)(C), that person shall payan operating reserve fee for each of those advisory reviewsequal to the advisory review fee for each submission estab-lished under paragraph (1)(E)(ii). Fees required by thissubparagraph shall be in addition to any fees requiredby subparagraph (A). Fees under this subparagraph shall

be due 20 days before any DTC advertisement is submittedby such person to the Secretary for advisory review.(D) LATE PAYMENT.

(i) IN GENERAL.Notwithstanding subparagraph(B), and subject to clause (ii), an operating reservefee shall be regarded as late if the person requiredto pay the fee has not paid the complete operatingreserve fee by

(I) for fiscal year 2008, 150 days after thedate of the enactment of the Food and Drug

Administration Amendments Act of 2007 or anearlier date specified by the Secretary; or

(II) in any subsequent year, November 1.(ii) COMPLETE PAYMENT.The complete operating

reserve fee shall be due and payable 20 days beforeany DTC advertisement is submitted by such personto the Secretary for advisory review.

(iii) AMOUNT.Notwithstanding any other provi-sion of this section, an operating reserve fee that isregarded as late under this subparagraph shall beequal to 150 percent of the operating reserve fee thatotherwise would have applied pursuant to subsection(d).

(b) ADVISORY REVIEW FEE REVENUE AMOUNTS.Fees undersubsection (a)(1) shall be established to generate revenue amountsof $6,250,000 for each of fiscal years 2008 through 2012, as adjustedpursuant to subsections (c) and (g)(4).

(c) ADJUSTMENTS.(1) INFLATION ADJUSTMENT.Beginning with fiscal year

2009, the revenues established in subsection (b) shall beadjusted by the Secretary by notice, published in the Federal

Register, for a fiscal year to reflect the greater of(A) the total percentage change that occurred in the

Consumer Price Index for all urban consumers (all items;U.S. city average), for the 12-month period ending June30 preceding the fiscal year for which fees are being estab-lished;

(B) the total percentage change for the previous fiscalyear in basic pay under the General Schedule in accordance

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with section 5332 of title 5, United States Code, as adjustedby any locality-based comparability payment pursuant tosection 5304 of such title for Federal employees stationed

in the District of Columbia; or(C) the average annual change in the cost, per full-time equivalent position of the Food and Drug Administra-tion, of all personnel compensation and benefits paid withrespect to such positions for the first 5 fiscal years ofthe previous 6 fiscal years.

The adjustment made each fiscal year by this subsection shallbe added on a compounded basis to the sum of all adjustmentsmade each fiscal year after fiscal year 2008 under this sub-section.

(2) WORKLOAD ADJUSTMENT.Beginning with fiscal year2009, after the fee revenues established in subsection (b) areadjusted for a fiscal year for inflation in accordance with para-graph (1), the fee revenues shall be adjusted further for suchfiscal year to reflect changes in the workload of the Secretary

with respect to the submission of DTC advertisements foradvisory review prior to initial dissemination. With respectto such adjustment:

(A) The adjustment shall be determined by the Sec-retary based upon the number of DTC advertisementsidentified pursuant to subsection (a)(1)(C) for the upcomingfiscal year, excluding allowable previously paid carry oversubmissions. The adjustment shall be determined by multi-plying the number of such advertisements projected forthat fiscal year that exceeds 150 by $27,600 (adjustedeach year beginning with fiscal year 2009 for inflationin accordance with paragraph (1)). The Secretary shallpublish in the Federal Register the fee revenues and feesresulting from the adjustment and the supporting meth-odologies.

(B) Under no circumstances shall the adjustmentresult in fee revenues for a fiscal year that are less thanthe fee revenues established for the prior fiscal year.(3) ANNUAL FEE SETTING FOR ADVISORY REVIEW.

(A) IN GENERAL.Not later than August 1 of eachfiscal year (or, with respect to fiscal year 2008, not laterthan 90 days after the date of the enactment of the Foodand Drug Administration Amendments Act of 2007), theSecretary shall establish for the next fiscal year the DTCadvertisement advisory review fee under subsection (a)(1),based on the revenue amounts established under subsection(b), the adjustments provided under paragraphs (1) and(2), and the number of DTC advertisements identifiedpursuant to subsection (a)(1)(C), excluding allowable pre-viously-paid carry over submissions. The annual advisory

review fee shall be established by dividing the fee revenuefor a fiscal year (as adjusted pursuant to this subsection)by the number of DTC advertisements so identified,excluding allowable previously-paid carry over submissionsunder subsection (a)(1)(F)(i).

(B) FISCAL YEAR 2008 FEE LIMIT.Notwithstandingsubsection (b) and the adjustments pursuant to this sub-section, the fee established under subparagraph (A) for

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fiscal year 2008 may not be more than $83,000 per submis-sion for advisory review.

(C) ANNUAL FEE LIMIT.Notwithstanding subsection

(b) and the adjustments pursuant to this subsection, thefee established under subparagraph (A) for a fiscal yearafter fiscal year 2008 may not be more than 50 percentmore than the fee established for the prior fiscal year.

(D) LIMIT.The total amount of fees obligated fora fiscal year may not exceed the total costs for such fiscalyear for the resources allocated for the process for theadvisory review of prescription drug advertising.

(d) OPERATING RESERVES.(1) IN GENERAL.The Secretary shall establish in the Food

and Drug Administration salaries and expenses appropriationaccount without fiscal year limitation a Direct-to-Consumer

Advisory Review Operating Reserve, of at least $6,250,000 infiscal year 2008, to continue the program under this sectionin the event the fees collected in any subsequent fiscal year

pursuant to subsection (a)(1) do not generate the fee revenueamount established for that fiscal year.(2) FEE SETTING.The Secretary shall establish the oper-

ating reserve fee under subsection (a)(2)(A) for each personrequired to pay the fee by multiplying the number of DTCadvertisements identified by that person pursuant to subsection(a)(1)(C) by the advisory review fee established pursuant tosubsection (c)(3) for that fiscal year, except that in no caseshall the operating reserve fee assessed be less than the oper-ating reserve fee assessed if the person had first participatedin the program under this section in fiscal year 2008.

(3) USE OF OPERATING RESERVE.The Secretary may usefunds from the reserves only to the extent necessary in anyfiscal year to make up the difference between the fee revenueamount established for that fiscal year under subsections (b)and (c) and the amount of fees actually collected for that fiscalyear pursuant to subsection (a)(1), or to pay costs of endingthe program under this section if it is terminated pursuantto subsection (f) or not reauthorized beyond fiscal year 2012.

(4) REFUND OF OPERATING RESERVES.Within 120 daysafter the end of fiscal year 2012, or if the program underthis section ends early pursuant to subsection (f), the Secretary,after setting aside sufficient operating reserve amounts toterminate the program under this section, shall refund allamounts remaining in the operating reserve on a pro ratabasis to each person that paid an operating reserve fee assess-ment. In no event shall the refund to any person exceed thetotal amount of operating reserve fees paid by such personpursuant to subsection (a)(2).(e) EFFECT OF FAILURE TO PAY FEES.Notwithstanding any

other requirement, a submission for advisory review of a DTC

advertisement submitted by a person subject to fees under sub-section (a) shall be considered incomplete and shall not be acceptedfor review by the Secretary until all fees owed by such personunder this section have been paid.

(f) EFFECT OF INADEQUATE FUNDING OF PROGRAM.(1) INITIAL FUNDING.If on November 1, 2007, or 120

days after the date of the enactment of the Food and DrugAdministration Amendments Act of 2007, whichever is later,

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the Secretary has not received at least $11,250,000 in advisoryreview fees and operating reserve fees combined, the programunder this section shall not commence and all collected fees

shall be refunded.(2) LATER FISCAL YEARS.Beginning in fiscal year 2009,if, on November 1 of the fiscal year, the combination of theoperating reserves, annual fee revenues from that fiscal year,and unobligated fee revenues from prior fiscal years falls below$9,000,000, adjusted for inflation (as described in subsection(c)(1)), the program under this section shall terminate, andthe Secretary shall notify all participants, retain any moneyfrom the unused advisory review fees and the operatingreserves needed to terminate the program, and refund theremainder of the unused fees and operating reserves. To theextent required to terminate the program, the Secretary shallfirst use unobligated advisory review fee revenues from priorfiscal years, then the operating reserves, and finally, unusedadvisory review fees from the relevant fiscal year.

(g) CREDITING ANDAVAILABILITY OF FEES.(1) IN GENERAL.Fees authorized under subsection (a)

shall be collected and available for obligation only to the extentand in the amount provided in advance in appropriations Acts.Such fees are authorized to remain available until expended.Such sums as may be necessary may be transferred from theFood and Drug Administration salaries and expenses appropria-tion account without fiscal year limitation to such appropriationaccount for salaries and expenses with such fiscal year limita-tion. The sums transferred shall be available solely for theprocess for the advisory review of prescription drug advertising.

(2) COLLECTIONS AND APPROPRIATION ACTS.(A) IN GENERAL.The fees authorized by this sec-

tion(i) shall be retained in each fiscal year in an

amount not to exceed the amount specified in appro-priation Acts, or otherwise made available for obliga-tion for such fiscal year; and

(ii) shall be available for obligation only if theamounts appropriated as budget authority for suchfiscal year are sufficient to support a number of full-time equivalent review employees that is not fewerthan the number of such employees supported in fiscalyear 2007.(B) REVIEW EMPLOYEES.For purposes of subpara-

graph (A)(ii), the term full-time equivalent reviewemployees means the total combined number of full-timeequivalent employees in

(i) the Center for Drug Evaluation and Research,Division of Drug Marketing, Advertising, and Commu-

nications, Food and Drug Administration; and(ii) the Center for Biologics Evaluation and

Research, Advertising and Promotional LabelingBranch, Food and Drug Administration.

(3) AUTHORIZATION OF APPROPRIATIONS.For each of thefiscal years 2008 through 2012, there is authorized to be appro-priated for fees under this section an amount equal to thetotal revenue amount determined under subsection (b) for the

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fiscal year, as adjusted pursuant to subsection (c) and para-graph (4) of this subsection, plus amounts collected for thereserve fund under subsection (d).

(4) OFFSET.Any amount of fees collected for a fiscalyear under this section that exceeds the amount of fees specifiedin appropriation Acts for such fiscal year shall be creditedto the appropriation account of the Food and Drug Administra-tion as provided in paragraph (1), and shall be subtractedfrom the amount of fees that would otherwise be collectedunder this section pursuant to appropriation Acts for a subse-quent fiscal year.(h) DEFINITIONS.For purposes of this section:

(1) The term advisory review means reviewing and pro-viding advisory comments on DTC advertisements regardingcompliance of a proposed advertisement with the requirementsof this Act prior to its initial public dissemination.

(2) The term advisory review fee has the meaningindicated for such term in subsection (a)(1)(D).

(3) The term carry over submission means a submissionfor an advisory review for which a fee was paid in one fiscalyear that is submitted for review in the following fiscal year.

(4) The term direct-to-consumer television advertisementmeans an advertisement for a prescription drug product (asdefined in section 735(3)) intended to be displayed on anytelevision channel for less than 3 minutes.

(5) The term DTC advertisement has the meaningindicated for such term in subsection (a)(1)(A).

(6) The term operating reserve fee has the meaningindicated for such term in subsection (a)(2)(A).

(7) The term person includes an individual, partnership,corporation, and association, and any affiliate thereof or suc-cessor in interest.

(8) The term process for the advisory review of prescrip-

tion drug advertising means the activities necessary to reviewand provide advisory comments on DTC advertisements priorto public dissemination and, to the extent the Secretary hasadditional staff resources available under the program underthis section that are not necessary for the advisory reviewof DTC advertisements, the activities necessary to review andprovide advisory comments on other proposed advertisementsand promotional material prior to public dissemination.

(9) The term resources allocated for the process for theadvisory review of prescription drug advertising means theexpenses incurred in connection with the process for theadvisory review of prescription drug advertising for

(A) officers and employees of the Food and DrugAdministration, contractors of the Food and Drug Adminis-tration, advisory committees, and costs related to such

officers, employees, and committees, and to contracts withsuch contractors;

(B) management of information, and the acquisition,maintenance, and repair of computer resources;

(C) leasing, maintenance, renovation, and repair offacilities and acquisition, maintenance, and repair of fix-tures, furniture, scientific equipment, and other necessarymaterials and supplies;


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(D) collection of fees under this section and accountingfor resources allocated for the advisory review of prescrip-tion drug advertising; and

(E) terminating the program under this section pursu-ant to subsection (f)(2) if that becomes necessary.(10) The term resubmission means a subsequent submis-

sion for advisory review of a direct-to-consumer televisionadvertisement that has been revised in response to the Sec-retarys comments on an original submission. A resubmissionmay not introduce significant new concepts or creative themesinto the television advertisement.

(11) The term submission for advisory review means anoriginal submission of a direct-to-consumer television advertise-ment for which the sponsor voluntarily requests advisory com-ments before the advertisement is publicly disseminated..

SEC. 105. REAUTHORIZATION; REPORTING REQUIREMENTS.

Part 2 of subchapter C of chapter VII (21 U.S.C. 379g etseq.), as amended by section 104, is further amended by inserting

after section 736A the following:SEC. 736B. REAUTHORIZATION; REPORTING REQUIREMENTS.

(a) PERFORMANCE REPORT.Beginning with fiscal year 2008,not later than 120 days after the end of each fiscal year for whichfees are collected under this part, the Secretary shall prepare andsubmit to the Committee on Energy and Commerce of the Houseof Representatives and the Committee on Health, Education, Labor,and Pensions of the Senate a report concerning the progress ofthe Food and Drug Administration in achieving the goals identifiedin the letters described in section 101(c) of the Food and Drug

Administration Amendments Act of 2007 during such fiscal yearand the future plans of the Food and Drug Administration formeeting the goals. The report for a fiscal year shall include informa-tion on all previous cohorts for which the Secretary has not given

a complete response on all human drug applications and supple-ments in the cohort.(b) FISCAL REPORT.Beginning with fiscal year 2008, not later

than 120 days after the end of each fiscal year for which feesare collected under this part, the Secretary shall prepare and submitto the Committee on Energy and Commerce of the House of Rep-resentatives and the Committee on Health, Education, Labor, andPensions of the Senate a report on the implementation of theauthority for such fees during such fiscal year and the use, bythe Food and Drug Administration, of the fees collected for suchfiscal year.

(c) PUBLIC AVAILABILITY.The Secretary shall make thereports required under subsections (a) and (b) available to thepublic on the Internet Web site of the Food and Drug Administra-tion.

(d) REAUTHORIZATION.

(1) CONSULTATION.In developing recommendations topresent to the Congress with respect to the goals, and plansfor meeting the goals, for the process for the review of humandrug applications for the first 5 fiscal years after fiscal year2012, and for the reauthorization of this part for such fiscalyears, the Secretary shall consult with

(A) the Committee on Energy and Commerce of theHouse of Representatives;

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(B) the Committee on Health, Education, Labor, andPensions of the Senate;

(C) scientific and academic experts;

(D) health care professionals;(E) representatives of patient and consumer advocacygroups; and

(F) the regulated industry.(2) PRIOR PUBLIC INPUT.Prior to beginning negotiations

with the regulated industry on the reauthorization of this part,the Secretary shall

(A) publish a notice in the Federal Register requestingpublic input on the reauthorization;

(B) hold a public meeting at which the public maypresent its views on the reauthorization, including specificsuggestions for changes to the goals referred to in sub-section (a);

(C) provide a period of 30 days after the public meetingto obtain written comments from the public suggesting

changes to this part; and(D) publish the comments on the Food and DrugAdministrations Internet Web site.(3) PERIODIC CONSULTATION.Not less frequently than

once every month during negotiations with the regulatedindustry, the Secretary shall hold discussions with representa-tives of patient and consumer advocacy groups to continuediscussions of their views on the reauthorization and theirsuggestions for changes to this part as expressed under para-graph (2).

(4) PUBLIC REVIEW OF RECOMMENDATIONS.After negotia-tions with the regulated industry, the Secretary shall

(A) present the recommendations developed underparagraph (1) to the Congressional committees specifiedin such paragraph;

(B) publish such recommendations in the Federal Reg-ister;

(C) provide for a period of 30 days for the publicto provide written comments on such recommendations;

(D) hold a meeting at which the public may presentits views on such recommendations; and

(E) after consideration of such public views and com-ments, revise such recommendations as necessary.(5) TRANSMITTAL OF RECOMMENDATIONS.Not later than

January 15, 2012, the Secretary shall transmit to the Congressthe revised recommendations under paragraph (4), a summaryof the views and comments received under such paragraph,and any changes made to the recommendations in responseto such views and comments.

(6) MINUTES OF NEGOTIATION MEETINGS.(A) PUBLIC AVAILABILITY.Before presenting the rec-

ommendations developed under paragraphs (1) through (5)to the Congress, the Secretary shall make publicly avail-able, on the public Web site of the Food and Drug Adminis-tration, minutes of all negotiation meetings conductedunder this subsection between the Food and Drug Adminis-tration and the regulated industry.

(B) CONTENT.The minutes described under subpara-graph (A) shall summarize any substantive proposal made

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by any party to the negotiations as well as significantcontroversies or differences of opinion during the negotia-tions and their resolution..

SEC. 106. SUNSET DATES.

(a) AUTHORIZATION.The amendments made by sections 102,103, and 104 cease to be effective October 1, 2012.

(b) REPORTING REQUIREMENTS.The amendment made by sec-tion 105 ceases to be effective January 31, 2013.

SEC. 107. EFFECTIVE DATE.

The amendments made by this title shall take effect on October1, 2007, or the date of the enactment of this Act, whichever islater, except that fees under part 2 of subchapter C of chapter

VII of the Federal Food, Drug, and Cosmetic Act shall be assessedfor all human drug applications received on or after October 1,2007, regardless of the date of the enactment of this Act.

SEC. 108. SAVINGS CLAUSE.

Notwithstanding section 509 of the Prescription Drug UserFee Amendments of 2002 (21 U.S.C. 379g note), and notwith-standing the amendments made by this title, part 2 of subchapterC of chapter VII of the Federal Food, Drug, and Cosmetic Act,as in effect on the day before the date of the enactment of thistitle, shall continue to be in effect with respect to human drugapplications and supplements (as defined in such part as of suchday) that on or after October 1, 2002, but before October 1, 2007,were accepted by the Food and Drug Administration for filingwith respect to assessing and collecting any fee required by suchpart for a fiscal year prior to fiscal year 2008.

SEC. 109. TECHNICAL AMENDMENT; CONFORMING AMENDMENT.

(a) Section 739 (21 U.S.C. 379j11) is amended in the matterpreceding paragraph (1) by striking subchapter and insertingpart.

(b) Paragraph (11) of section 739 (21 U.S.C. 379j11) is amendedby striking 735(9) and inserting 735(11).

TITLE IIMEDICAL DEVICE USER FEEAMENDMENTS OF 2007

SEC. 201. SHORT TITLE; REFERENCES IN TITLE; FINDING.

(a) SHORT TITLE.This title may be cited as the MedicalDevice User Fee Amendments of 2007.

(b) REFERENCES IN TITLE.Except as otherwise specified,amendments made by this title to a section or other provisionof law are amendments to such section or other provision of theFederal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

(c) FINDING.The Congress finds that the fees authorized under

the amendments made by this title will be dedicated toward expe-diting the process for the review of device applications and forassuring the safety and effectiveness of devices, as set forth inthe goals identified for purposes of part 3 of subchapter C ofchapter VII of the Federal Food, Drug, and Cosmetic Act in theletters from the Secretary of Health and Human Services to theChairman of the Committee on Health, Education, Labor, and Pen-sions of the Senate and the Chairman of the Committee on Energy

21 USC 379i

note.

21 USC 301 note.

Medical DeviceUser FeeAmendments of2007.

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and Commerce of the House of Representatives, as set forth inthe Congressional Record.

Subtitle AFees Related to MedicalDevices

SEC. 211. DEFINITIONS.

Section 737 is amended(1) in the matter preceding paragraph (1), by striking For

purposes of this subchapter and inserting For purposes ofthis part;

(2) by redesignating paragraphs (5), (6), (7), and (8) asparagraphs (8), (9), (10), and (12), respectively;

(3) by inserting after paragraph (4) the following:(5) The term 30-day notice means a notice under section

515(d)(6) that is limited to a request to make modificationsto manufacturing procedures or methods of manufacture

affecting the safety and effectiveness of the device.(6) The term request for classification information meansa request made under section 513(g) for information respectingthe class in which a device has been classified or the require-ments applicable to a device.

(7) The term annual fee, for periodic reporting concerninga class III device, means the annual fee associated with periodicreports required by a premarket application approval order.;

(4) in paragraph (10), as so redesignated(A) by striking April of the preceding fiscal year

and inserting October of the preceding fiscal year; and(B) by striking April 2002 and inserting October

2001;(5) by inserting after paragraph (10), as so amended, the

following:

(11) The term person includes an affiliate thereof.; and(6) by inserting after paragraph (12), as so redesignated,the following:

(13) The term establishment subject to a registration feemeans an establishment that is required to register with theSecretary under section 510 and is one of the following typesof establishments:

(A) MANUFACTURER.An establishment that makesby any means any article that is a device, including anestablishment that sterilizes or otherwise makes sucharticle for or on behalf of a specification developer or anyother person.

(B) SINGLE-USE DEVICE REPROCESSOR.An establish-ment that, within the meaning of section 201(ll)(2)(A), per-forms additional processing and manufacturing operationson a single-use device that has previously been used on

a patient.(C) SPECIFICATION DEVELOPER.An establishment

that develops specifications for a device that is distributedunder the establishments name but which performs nomanufacturing, including an establishment that, in addi-tion to developing specifications, also arranges for themanufacturing of devices labeled with another establish-ments name by a contract manufacturer..

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SEC. 212. AUTHORITY TO ASSESS AND USE DEVICE FEES.

(a) TYPES OF FEES.(1) IN GENERAL.Section 738(a) (21 U.S.C. 379j(a)) is

amended(A) in paragraph (1), by striking Beginning on the

date of the enactment of the Medical Device User Feeand Modernization Act of 2002 and inserting Beginningin fiscal year 2008; and

(B) by amending the designation and heading of para-graph (2) to read as follows:(2) PREMARKET APPLICATION, PREMARKET REPORT, SUPPLE-

MENT, AND SUBMISSION FEE, AND ANNUAL FEE FOR PERIODICREPORTING CONCERNING A CLASS III DEVICE..

(2) FEE AMOUNTS.Section 738(a)(2)(A) (21 U.S.C.379j(a)(2)(A)) is amended

(A) in clause (iii), by striking a fee equal to the feethat applies and inserting a fee equal to 75 percentof the fee that applies;

(B) in clause (iv), by striking 21.5 percent andinserting 15 percent;(C) in clause (v), by striking 7.2 percent and inserting

7 percent;(D) by redesignating clauses (vi) and (vii) as clauses

(vii) and (viii), respectively;(E) by inserting after clause (v) the following:

(vi) For a 30-day notice, a fee equal to 1.6 percentof the fee that applies under clause (i).;(F) in clause (viii), as so redesignated

(i) by striking 1.42 percent and inserting 1.84percent; and

(ii) by striking , subject to any adjustment undersubsection (e)(2)(C)(ii); and(G) by inserting after such clause (viii) the following:

(ix) For a request for classification information,a fee equal to 1.35 percent of the fee that appliesunder clause (i).

(x) For periodic reporting concerning a class IIIdevice, an annual fee equal to 3.5 percent of the feethat applies under clause (i)..

(3) PAYMENT.Section 738(a)(2)(C) (21 U.S.C. 379j(a)(2)(C))is amended to read as follows:

(C) PAYMENT.The fee required by subparagraph (A)shall be due upon submission of the premarket application,premarket report, supplement, premarket notificationsubmission, 30-day notice, request for classificationinformation, or periodic reporting concerning a class IIIdevice. Applicants submitting portions of applicationspursuant to section 515(c)(4) shall pay such fees uponsubmission of the first portion of such applications..

(4) REFUNDS.Section 738(a)(2)(D) (21 U.S.C. 379j(a)(2)(D))is amended

(A) in clause (iii), by striking the last two sentences;and

(B) by adding after clause (iii) the following:(iv) MODULAR APPLICATIONS WITHDRAWN BEFORE

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under section 515(c)(4) that is withdrawn before asecond portion is submitted and before a first actionon the first portion.

(v) LATER WITHDRAWN MODULAR APPLICATIONS.If an application submitted under section 515(c)(4) iswithdrawn after a second or subsequent portion issubmitted but before any first action, the Secretarymay return a portion of the fee. The amount of refund,if any, shall be based on the level of effort alreadyexpended on the review of the portions submitted.

(vi) SOLE DISCRETION TO REFUND.The Secretaryshall have sole discretion to refund a fee or portionof the fee under clause (iii) or (v). A determinationby the Secretary concerning a refund under clause(iii) or (v) shall not be reviewable..

(5) ANNUAL ESTABLISHMENT REGISTRATION FEE.Section738(a) (21 U.S.C. 379j(a)) is amended by adding after paragraph(2) the following:

(3) ANNUAL ESTABLISHMENT REGISTRATION FEE.(A) IN GENERAL.Except as provided in subparagraph(B), each establishment subject to a registration fee shallbe subject to a fee for each initial or annual registrationunder section 510 beginning with its registration for fiscalyear 2008.

(B) EXCEPTION.No fee shall be required undersubparagraph (A) for an establishment operated by a Stateor Federal governmental entity or an Indian tribe (asdefined in the Indian Self Determination and Educational

Assistance Act), unless a device manufactured by theestablishment is to be distributed commercially.

(C) PAYMENT.The fee required under subparagraph(A) shall be due once each fiscal year, upon the initialregistration of the establishment or upon the annual reg-istration under section 510..

(b) FEE AMOUNTS.Section 738(b) (21 U.S.C. 379j(b)) isamended to read as follows:

(b) FEE AMOUNTS.Except as provided in subsections (c), (d),(e), and (h) the fees under subsection (a) shall be based on thefollowing fee amounts:

Fee TypeFiscalYear2008

FiscalYear2009

FiscalYear2010

FiscalYear2011

FiscalYear2012

Premarket Application .... $185,000 $200,725 $217,787 $236,298 $256,384................

Establishment Registra-

tion ................................ $1,706 $1,851 $2,008 $2,179 $2,364..

(c) ANNUAL FEE SETTING.(1) IN GENERAL.Section 738(c) (21 U.S.C. 379j(c)(1)) is

amended(A) in the subsection heading, by striking Annual

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(2) ADJUSTMENT OF ANNUAL ESTABLISHMENT FEE.Section738(c) (21 U.S.C. 379j(c)), as amended by paragraph (1), isfurther amended

(A) by redesignating paragraphs (2) and (3) as para-graphs (3) and (4), respectively;

(B) by inserting after paragraph (1) the following:(2) ADJUSTMENT.

(A) IN GENERAL.When setting fees for fiscal year2010, the Secretary may increase the fee under subsection(a)(3)(A) (applicable to establishments subject to registra-tion) only if the Secretary estimates that the number ofestablishments submitting fees for fiscal year 2009 is fewerthan 12,250. The percentage increase shall be the percent-age by which the estimate of establishments submittingfees in fiscal year 2009 is fewer than 12,750, but in nocase may the percentage increase be more than 8.5 percentover that specified in subsection (b) for fiscal year 2010.If the Secretary makes any adjustment to the fee undersubsection (a)(3)(A) for fiscal year 2010, then such fee forfiscal years 2011 and 2012 shall be adjusted so that suchfee for fiscal year 2011 is equal to the adjusted fee forfiscal year 2010 increased by 8.5 percent, and such feefor fiscal year 2012 is equal to the adjusted fee for fiscalyear 2011 increased by 8.5 percent.

(B) PUBLICATION.For any adjustment made undersubparagraph (A), the Secretary shall publish in the Fed-eral Register the Secretarys determination to make theadjustment and the rationale for the determination.; and

(C) in paragraph (4), as redesignated by this para-graph, in subparagraph (A)

(i) by striking For fiscal years 2006 and 2007,the Secretary and inserting The Secretary; and

(ii) by striking for the first month of fiscal year2008 and inserting for the first month of the nextfiscal year.

(d) SMALL BUSINESSES; FEE WAIVER AND FEE REDUCTIONREGARDING PREMARKETAPPROVAL.

(1) IN GENERAL.Section 738(d)(1) (21 U.S.C. 379j(d)(1))is amended

(A) by striking , partners, and parent firms; and(B) by striking clauses (i) through (vi) of subsection

(a)(2)(A) and inserting clauses (i) through (v) and clauses(vii), (ix), and (x) of subsection (a)(2)(A).(2) RULES RELATING TO PREMARKET APPROVAL FEES.

(A) DEFINITION.Section 738(d)(2)(A) (21 U.S.C.379j(d)(2)(A)) is amended by striking , partners, andparent firms.

(B) EVIDENCE OF QUALIFICATION.Section 738(d)(2)(B)(21 U.S.C. 379j(d)(2)(B)) is amended(i) by striking (B) EVIDENCE OF QUALIFICATION.

An applicant and inserting the following:(B) EVIDENCE OF QUALIFICATION.

(i) IN GENERAL.An applicant;(ii) by striking The applicant shall support its

claim and inserting the following:



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(ii) FIRMS SUBMITTING TAX RETURNS TO THEUNITED STATES INTERNAL REVENUE SERVICE.Theapplicant shall support its claim;

(iii) by striking , partners, and parent firms eachplace it appears;(iv) by striking the last sentence and inserting

If no tax forms are submitted for any affiliate, theapplicant shall certify that the applicant has no affili-ates.; and

(v) by adding at the end the following:(iii) FIRMS NOT SUBMITTING TAX RETURNS TO THE

UNITED STATES INTERNAL REVENUE SERVICE.In thecase of an applicant that has not previously submitteda Federal income tax return, the applicant and eachof its affiliates shall demonstrate that it meets thedefinition under subparagraph (A) by submission ofa signed certification, in such form as the Secretarymay direct through a notice published in the Federal

Register, that the applicant or affiliate meets the cri-teria for a small business and a certification, inEnglish, from the national taxing authority of thecountry in which the applicant or, if applicable, affiliateis headquartered. The certification from such taxingauthority shall bear the official seal of such taxingauthority and shall provide the applicants or affiliatesgross receipts or sales for the most recent year inboth the local currency of such country and in UnitedStates dollars, the exchange rate used in convertingsuch local currency to dollars, and the dates duringwhich these receipts or sales were collected. Theapplicant shall also submit a statement signed by thehead of the applicants firm or by its chief financialofficer that the applicant has submitted certificationsfor all of its affiliates, or that the applicant has noaffiliates..

(3) REDUCED FEES.Section 738(d)(2)(C) (21 U.S.C.379j(d)(2)(C)) is amended to read as follows:

(C) REDUCED FEES.Where the Secretary finds thatthe applicant involved meets the definition under subpara-graph (A), the fees established under subsection (c)(1) maybe paid at a reduced rate of

(i) 25 percent of the fee established under suchsubsection for a premarket application, a premarketreport, a supplement, or periodic reporting concerninga class III device; and

(ii) 50 percent of the fee established under suchsubsection for a 30-day notice or a request for classifica-tion information..

(e) SMALL BUSINESSES; FEE REDUCTION REGARDING PREMARKET

NOTIFICATION SUBMISSIONS.(1) IN GENERAL.Section 738(e)(1) (21 U.S.C. 379j(e)(1))

is amended(A) by striking 2004 and inserting 2008; and(B) by striking (a)(2)(A)(vii) and inserting

(a)(2)(A)(viii).(2) RULES RELATING TO PREMARKET NOTIFICATION SUBMIS-

SIONS.

Certification.Federal Register,publication.


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(A) DEFINITION.Section 738(e)(2)(A) (21 U.S.C.379j(e)(2)(A)) is amended by striking , partners, and parentfirms.

(B) EVIDENCE OF QUALIFICATION.Section 738(e)(2)(B)(21 U.S.C. 379j(e)(2)(B)) is amended(i) by striking (B) EVIDENCE OF QUALIFICATION.

An applicant and inserting the following:(B) EVIDENCE OF QUALIFICATION.

(i) IN GENERAL.An applicant;(ii) by striking The applicant shall support its

claim and inserting the following:(ii) FIRMS SUBMITTING TAX RETURNS TO THE

UNITED STATES INTERNAL REVENUE SERVICE.Theapplicant shall support its claim;

(iii) by striking , partners, and parent firms eachplace it appears;

(iv) by striking the last sentence and insertingIf no tax forms are submitted for any affiliate, the

applicant shall certify that the applicant has no affili-ates.; and(v) by adding at the end the following:(iii) FIRMS NOT SUBMITTING TAX RETURNS TO THE

UNITED STATES INTERNAL REVENUE SERVICE.In thecase of an applicant that has not previously submitteda Federal income tax return, the applicant and eachof its affiliates shall demonstrate that it meets thedefinition under subparagraph (A) by submission ofa signed certification, in such form as the Secretarymay direct through a notice published in the FederalRegister, that the applicant or affiliate meets the cri-teria for a small business and a certification, inEnglish, from the national taxing authority of thecountry in which the applicant or, if applicable, affiliateis headquartered. The certification from such taxingauthority shall bear the official seal of such taxingauthority and shall provide the applicants or affiliatesgross receipts or sales for the most recent year inboth the local currency of such country and in UnitedStates dollars, the exchange rate used in convertingsuch local currency to dollars, and the dates duringwhich these receipts or sales were collected. Theapplicant shall also submit a statement signed by thehead of the applicants firm or by its chief financialofficer that the applicant has submitted certificationsfor all of its affiliates, or that the applicant has noaffiliates..

(3) REDUCED FEES.Section 738(e)(2)(C) (21 U.S.C.379j(e)(2)(C)) is amended to read as follows:

(C) REDUCED FEES.For fiscal year 2008 and each

subsequent fiscal year, where the Secretary finds that theapplicant involved meets the definition under subparagraph(A), the fee for a premarket notification submission maybe paid at 50 percent of the fee that applies under sub-section (a)(2)(A)(viii), and as established under subsection(c)(1)..

(f) EFFECT OF FAILURE TO PAY FEES.Section 738(f) (21 U.S.C.379j(f)) is amended to read as follows:

Certification.Federal Register,publication.


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(f) EFFECT OF FAILURE TO PAY FEES.(1) NO ACCEPTANCE OF SUBMISSIONS.A premarket

application, premarket report, supplement, premarket notifica-

tion submission, 30-day notice, request for classificationinformation, or periodic reporting concerning a class III devicesubmitted by a person subject to fees under subsections (a)(2)and (a)(3) shall be considered incomplete and shall not beaccepted by the Secretary until all fees owed by such personhave been paid.

(2) NO REGISTRATION.Registration information submittedunder section 510 by an establishment subject to a registrationfee shall be considered incomplete and shall not be acceptedby the Secretary until the registration fee under subsection(a)(3) owed for the establishment has been paid. Until thefee is paid and the registration is complete, the establishmentis deemed to have failed to register in accordance with section510..(g) CONDITIONS.Section 738(g) (21 U.S.C. 379j(g)) is

amended(1) by striking paragraph (1) and inserting the following:(1) PERFORMANCE GOALS; TERMINATION OF PROGRAM.

With respect to the amount that, under the salaries andexpenses account of the Food and Drug Administration, isappropriated for a fiscal year for devices and radiological prod-ucts, fees may not be assessed under subsection (a) for thefiscal year, and the Secretary is not expected to meet anyperformance goals identified for the fiscal year, if

(A) the amount so appropriated for the fiscal year,excluding the amount of fees appropriated for the fiscalyear, is more than 1 percent less than $205,720,000 multi-plied by the adjustment factor applicable to such fiscalyear; or

(B) fees were not assessed under subsection (a) for

the previous fiscal year.; and(2) by amending paragraph (2) to read as follows:(2) AUTHORITY.If the Secretary does not assess fees

under subsection (a) during any portion of a fiscal year becauseof paragraph (1) and if at a later date in such fiscal yearthe Secretary may assess such fees, the Secretary may assessand collect such fees, without any modification in the ratefor premarket applications, supplements, premarket reports,premarket notification submissions, 30-day notices, requestsfor classification information, periodic reporting concerning aclass III device, and establishment registrations at any timein such fiscal year, notwithstanding the provisions of subsection(a) relating to the date fees are to be paid..(h) CREDITING ANDAVAILABILITY OF FEES.

(1) AUTHORIZATION OF APPROPRIATIONS.Section 738(h)(3)

(21 U.S.C. 379j(h)(3)) is amended to read as follows:(3) AUTHORIZATIONS OF APPROPRIATIONS.There are

authorized to be appropriated for fees under this section(A) $48,431,000 for fiscal year 2008;(B) $52,547,000 for fiscal year 2009;(C) $57,014,000 for fiscal year 2010;(D) $61,860,000 for fiscal year 2011; and(E) $67,118,000 for fiscal year 2012..


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(2) OFFSET.Section 738(h)(4) (21 U.S.C. 379j(h)(3)) isamended to read as follows:

(4) OFFSET.If the cumulative amount of fees collected

during fiscal years 2008, 2009, and 2010, added to the amountestimated to be collected for fiscal year 2011, which estimateshall be based upon the amount of fees received by the Sec-retary through June 30, 2011, exceeds the amount of feesspecified in aggregate in paragraph (3) for these four fiscalyears, the aggregate amount in excess shall be credited tothe appropriation account of the Food and Drug Administrationas provided in paragraph (1), and shall be subtracted fromthe amount of fees that would otherwise be authorized to becollected under this section pursuant to appropriation Actsfor fiscal year 2012..

SEC. 213. REAUTHORIZATION; REPORTING REQUIREMENTS.

Part 3 of subchapter C of chapter VII is amended by insertingafter section 738 the following:

SEC. 738A. REAUTHORIZATION; REPORTING REQUIREMENTS.

(a) REPORTS.(1) PERFORMANCE REPORT.For fiscal years 2008 through

2012, not later than 120 days after the end of each fiscalyear during which fees are collected under this part, the Sec-retary shall prepare and submit to the Committee on Health,Education, Labor, and Pensions of the Senate and the Com-mittee on Energy and Commerce of the House of Representa-tives, a report concerning the progress of the Food and Drug

Administration in achieving the goals identified in the lettersdescribed in section 201(c) of the Food and Drug Administration

Amendments Act of 2007 during such fiscal year and the futureplans of the Food and Drug Administration for meeting thegoals. The report for a fiscal year shall include informationon all previous cohorts for which the Secretary has not givena complete response on all device premarket applications andreports, supplements, and premarket notifications in the cohort.

(2) FISCAL REPORT.For fiscal years 2008 through 2012,not later than 120 days after the end of each fiscal year duringwhich fees are collected under this part, the Secretary shallprepare and submit to the Committee on Health, Education,Labor, and Pensions of the Senate and the Committee onEnergy and Commerce of the House of Representatives, a reporton the implementation of the authority for such fees duringsuch fiscal year and the use, by the Food and Drug Administra-tion, of the fees collected during such fiscal year for whichthe report is made.

(3) PUBLIC AVAILABILITY.The Secretary shall make thereports required under paragraphs (1) and (2) available tothe public on the Internet Web site of the Food and Drug

Administration.(b) REAUTHORIZATION.

(1) CONSULTATION.In developing recommendations topresent to Congress with respect to the goals, and plans formeeting the goals, for the process for the review of deviceapplications for the first 5 fiscal years after fiscal year 2012,and for the reauthorization of this part for such fiscal years,the Secretary shall consult with

Website.

21 USC 379j1.


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(A) the Committee on Energy and Commerce of theHouse of Representatives;

(B) the Committee on Health, Education, Labor, and

Pensions of the Senate;(C) scientific and academic experts;(D) health care professionals;(E) representatives of patient and consumer advocacy

groups; and(F) the regulated industry.

(2) PRIOR PUBLIC INPUT.Prior to beginning negotiationswith the regulated industry on the reauthorization of this part,the Secretary shall

(A) publish a notice in the Federal Register requestingpublic input on the reauthorization;

(B) hold a public meeting at which the public maypresent its views on the reauthorization, including specificsuggestions for changes to the goals referred to in sub-section (a)(1);

(C) provide a period of 30 days after the public meetingto obtain written comments from the public suggestingchanges to this part; and

(D) publish the comments on the Food and DrugAdministrations Internet Web site.(3) PERIODIC CONSULTATION.Not less frequently than

once every month during negotiations with the regulatedindustry, the Secretary shall hold discussions with representa-tives of patient and consumer advocacy groups to continuediscussions of their views on the reauthorization and theirsuggestions for changes to this part as expressed under para-graph (2).

(4) PUBLIC REVIEW OF RECOMMENDATIONS.After negotia-tions with the regulated industry, the Secretary shall

(A) present the recommendations developed underparagraph (1) to the Congressional committees specifiedin such paragraph;

(B) publish such recommendations in the Federal Reg-ister;

(C) provide for a period of 30 days for the publicto provide written comments on such recommendations;

(D) hold a meeting at which the public may presentits views on such recommendations; and

(E) after consideration of such public views and com-ments, revise such recommendations as necessary.(5) TRANSMITTAL OF RECOMMENDATIONS.Not later than

January 15, 2012, the Secretary shall transmit to Congressthe revised recommendations under paragraph (4), a summaryof the views and comments received under such paragraph,and any changes made to the recommendations in responseto such views and comments.

(6) MINUTES OF NEGOTIATION MEETINGS.(A) PUBLIC AVAILABILITY.Before presenting the rec-

ommendations developed under paragraphs (1) through (5)to the Congress, the Secretary shall make publicly avail-able, on the public Web site of the Food and Drug Adminis-tration, minutes of all negotiation meetings conductedunder this subsection between the Food and Drug Adminis-tration and the regulated industry.

Website.

Deadline.


Website.



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(B) CONTENT.The minutes described under subpara-graph (A) shall summarize any substantive proposal madeby any party to the negotiations as well as significant

controversies or differences of opinion during the negotia-tions and their resolution..

SEC. 214. SAVINGS CLAUSE.

Notwithstanding section 107 of the Medical Device User Feeand Modernization Act of 2002 (Public Law 107250), and notwith-standing the amendments made by this subtitle, part 3 of sub-chapter C of chapter VII of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 379i et seq.), as in effect on the day before thedate of the enactment of this subtitle, shall continue to be ineffect with respect to premarket applications, premarket reports,premarket notification submissions, and supplements (as definedin such part as of such day) that on or after October 1, 2002,but before October 1, 2007, were acc

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